Thursday, August 6, 2015

CMS Announces Members of Lab Advisory Panel; First Meeting 8/26/2015

CMS has announced the experts it has selected for a fifteen-member expert advisory panel on laboratory policy. The panel will hold its first public meeting on August 26, 2015.

The panel will specifically give CMS an opportunity to reopen and revisit issues about molecular test crosswalking and issues on drugs of abuse testing that were discussed at a prior July 26, 2015 public meeting (here). Details after the break. Updated August 20, 2015 with additional information about each panelist.

CMS released a public announcement that it has selected the members of an expert advisory committee on laboratory policy. Authorization for this new federal advisory panel was created by PAMA - the Protecting Access to Medicare Act of April 2014, which also created a new and evolving payment system for lab tests based on market prices of commercial payers.

The charter for the panel is:

Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (Secretary) to consult with an expert outside advisory panel, established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests.

Such individuals may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics.

The Panel will provide input and recommendations to the Secretary and theAdministrator, Centers for Medicare & Medicaid Services (CMS), on the following:● The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test;● The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and● Other aspects of the new payment system under section 1834A of the Act.

Specifically for THIS meeting, the August 26 panel will focus on crosswalk issues for new tests and policy and pricing for drugs of abuse testing.

Members of the panel are:

ThePanel willconsistofthe
followingmembers
and aChair:

● StevePhurrough M.D., PanelChair,
CMSMedical Officer

● GeoffreyBaird, M.D.,
Ph.D.

● Vickie Baselski,
Ph.D.

● Stephen
N. Bauer, M.D.

● WilliamClarke, Ph.D., M.B.A.,
DABCC,
FACB

● Judith
Davis, M.S.

● StanleyR. Hamilton,
M.D.

● Curtis
A. Hanson, M.D.

● KandiceKottke-Marchant, M.D.,
Ph.D.

● RajuKucherlapati,
Ph.D.

● BryanA.Loy, M.D.,
M.B.A.

● GailMarcus, M.S.E., M.B.A.

● Carl Morrison,
M.D., D.V.M.

● VictoriaM. Pratt, Ph.D., FACMG

● Michele
M. Schoonmaker, Ph.D.

● RebeccaSutphen, M.D.

Further information, including the chance to register for the public workshop in Baltimore on August 26, is here on the CMS website. (Registration open August 7-14).

For my April, 2014 discussion of the panel as proposed in legislation, here.

The CMS announcement provides only names; below are title and internet links where these were clearly available from the name alone:

About the Author

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.